International phase I/II protocols for pancreatic cancer are expanded to include all solid tumors |
Advanced pancreatic cancer, expanded to include metastatic melanoma, breast, uterus, colon cancer, and leiomyosarcoma |
Demonstrations of overall safety, lack of toxicity, and potential for clinical efficacy is established; a dose-response calculus is advanced |
(90,91) |
Phase I (USA) low-dose safety study in advanced or metastatic pancreatic Ca |
Advanced pancreatic cancer |
General safety is confirmed; no RCR no inactivating antibodies; no DLT, enabled further dose escalation(s) |
(92) |
Phase I/II dose escalation studies of safety and efficacy |
Chemotherapy-resistant sarcoma, breast cancer and pancreatic cancer |
Demonstrates significant anticancer activity (efficacy) without toxicity |
(93,94) |
Phase I/II with advanced phase II study of resistant sarcoma and osteosarcoma |
Chemotherapy-resistant sarcoma and osteosarcoma |
Safety and dose-dependent clinical efficacy is demonstrated; significant improvements in overall survival |
(95,96) |
Advanced phase I/II study of chemotherapy-resistant metastatic pancreatic Ca |
Advanced pancreatic cancer |
Safety and dose-dependent clinical efficacy is demonstrated; significant improvements in overall survival |
(97) |